Friday, March 28, 2008

Score One for Research Integrity in the Journals

The latest "HeartWire," a pretty reasonable alerting service from WebMD, heartens us in its account of courts protecting journalistic research integrity over Big Pharma's latest attempts, this time from Pfizer, to wield the meat-axe of the subpoena.

In a Federal district Copurt in Chicago, it seems, Magistrate Judge Arlander Keys ruled that journals--in this case, JAMA--won't have to give up its critical preservation of peer-reviewer confidentiality.

You'll have guessed that this is all about Pfizer's attempts to get out of its Celebrex jam. They wanted nothing less than the actual submitted, including rejected, manuscripts, peer reviewers' identities, and the actual comments passed back and forth between editors and reviewers.

It would have had a chilling effect had this attempt to erode the integrity of the peer review process been even minimally successful. What's chilling too is the fact that Pfizer--or, let's face it, their highly compensated attorneys--could make such a brazen attempt to have a go at the basic trust so necessary to the edifice of research integrity.

What's encouraging, though, is that Judge Keys saw those attempts for what they were.

4 comments:

MarilynMann said...

1. Pfizer's attorneys may have viewed this as zealous representation, consistent with their duties to their client.

2. The fact that an attorney makes a certain argument on behalf of a client does not mean he/she necessarily believes that the argument is consistent with good public policy.

3. How are Pfizer's compensation arrangements with its counsel relevant? The journals may have also had highly compensated counsel.

4. The system worked here. What is the problem? In the future, counsel to pharmaceutical companies will have these precedents available and will be likely to advise their clients not to pursue this line of attack.

Marilyn

MarilynMann said...

As you probably guessed, I'm an attorney. I work for a federal agency and I spend a lot of time talking to "highly compensated" attorneys, usually from large law firms. It often happens that counsel will advance an argument because they feel their duty to their client requires it or because their client wants them to make the argument. If their legal theory is unlikely to get any traction, I'll often just tell them so. This gets them off the hook with their client and saves everybody time. There is even something we call a "paper bag argument." That's the kind that you make wishing you had a paper bag over your head.

Marilyn

MarilynMann said...

OK, sorry about the multiple comments, but I went on Lexis and printed out the opinion. In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, 2008 U.S. Dist. LEXIS 21098.
It seems that Pfizer had originally sought the identities of the peer reviewers but later dropped that request. Counsel to Pfizer was John W. Christopher, a partner at Winston & Strawn. Counsel for the AMA was Matthew Crowl, partner at Schiff Hardin and Joseph Thornton, an in-house attorney for JAMA. Of possible interest (if not relevance) is that Christopher also represents Philip Morris. Here's his bio:
http://www.winston.com/index.cfm?contentID=24&itemID=11100
Here's Crowl's bio:
http://www.schiffhardin.com/MatthewCCrowl.htm
Looks like both sides were adequately represented.

Also of interest is that the court did not find that the documents were privileged. Rather the court found that the subpoenaed documents had little, if any, probative value, and that "it is not unreasonable to believe that compelling production of peer review documents would compromise the [peer review] process."

Marilyn

Anonymous said...

The Forgotten Benefits of Aspirin

Almost on a daily basis, one may read about a new medication being developed or approved for the benefit of patients. At times, these announcements may praise the innovation and novelty of such drugs that are new and possibly available to all in need of it.
But it’s possible the one super drug is not new and really is a super drug. In fact, it’s one of the oldest medications available, and that would be aspirin- the first non-steroidal anti-inflammatory drug (NSAID).
Noted as ASA by doctors typically, aspirin effects have been noted for thousands of years, as the active ingredient comes from the bark of a White Willow tree, and long ago, patients with pain or a fever would chew on this bark for relief.
Fast forward to over a hundred years ago and Bayer pharmaceuticals (pronounced ‘Beier’), which is the same company that brought us heroin and mustard gas, as well as methadone. The company originated in Germany, but presently has its U.S. headquarters in New York. Felix Hoffman, seeking to develop an agent for his father’s rheumatism, was involved in the development of what is known now as aspirin. And it was a difficult task to develop this drug, as it was toxic to the stomach due to the nature of the active ingredient again obtained from the bark of the white willow tree. Dr. Hoffman and others at Bayer developed a drug that proved to be tolerable to patients while keeping the active ingredient in tact through a method of delivery developed by Dr. Hoffman’s team at Bayer. After launching the medication, aspirin was priced at about 50 cents an ounce, as at the time it was only available in power form. Soon before 1920, aspirin developed the tablet form of the drug and was then available by prescription. Regardless, aspirin was responsible for one third of sales for Bayer during this time, due to its popularity at that time.
While all drugs have side effects, aspirin is one of very few drugs that provides great efficacy and indications, with limited side effects. In fact, some of aspirin’s additional uses have been recently discovered. This may be why the New York Times called aspirin a wonder drug in the 1960s. In the 1970s, the mechanism of aspirin was isolated, which is the blockage of prostaglandins.
With Aspirin and its potential life-extending benefits:
Aspirin has been associated with decreased risk of asthma and prostate cancer in the elderly. Also, aspirin has been linked with lowering the risk of breast cancer and colon cancer as well. Aspirin is a blood thinner, and has been associated with decreasing the risk of heart attacks and strokes in certain patient populations, as the drug prevents clots. This was first suggested in the 1940s and the FDA suggested that it be the drug of choice for those who experienced a heart attack over a decade ago. Aspirin intake is beneficial for those after coronary bypass procedures. A topical formulation of aspirin was developed recently for those experiencing Herpes pain. The drug has been proven beneficial for those experiencing migraine pains. Aspirin at low doses is taken by many as a preventive drug to decrease cardiovascular incidents that may occur.
Aspirin has been the best selling painkiller since the 1950s. It is not as addictive as other choices for patients regarding pain relief in particular. It is also the most studied drug- with over 3000 scientific papers published worldwide. Also, over 15 billion tablets of aspirin are sold annually, which amounts to about 80 million aspirin tablets consumed daily by others. This amounts to over 16,000 tons of aspirin consumed during this time, or about 70,000 metric tons of aspirin a year. Over a decade ago, a study was performed and concluded that twice as many people would choose aspirin over a computer, given the two choices, because of the benefits of the drug.
Side effects would include GI bleeding if taken in large amounts, along with an association of Reye’s syndrome in children, yet both are relatively rare. Yet all things considered, clearly the benefits of aspirin outweigh any risks of the drug.
Lately, there have been issues with other NSAIDs, such as Cox II inhibitors, without full recollection or knowledge that aspirin is in fact the world’s most widely used drug, and for good reasons.
At times, something newer is not always better

“We might die from medication, but we sure killed all the pain.” --- Conor Oberst

Dan Abshear